After gaining market access under a contingency plan by USFDA, Sun Pharmaceutical Industries is awaiting approval from the health regulator for its cancer drug Lipodox.
The company's temporary supply of the drug to the US is set to come to an end with the US Food and Drug Administration (USFDA) restoring supply of Doxil from Janssen Products, LP after it was stopped earlier this year due to manufacturing and quality issues.
"We have an ANDA awaiting approval with the USFDA, but when to clear the application is entirely the agency's decision," a spokesperson of Sun Pharmaceutical said.
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